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FDA MedWatch Program

Reporting Adverse Drug Reactions

MedWatch is an FDA program for reporting "serious reactions" resulting from a prescription medication. The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes:

  • Patient's Death: when adverse reaction to drug is the suspected cause of death
  • Life-Threatening Condition: serious side-effect put patient at real risk of dying
  • Hospitalization: admitted because of serious adverse reaction to medication
  • Permanent Disability: strokes; nervous system disorders; other impairment
  • Birth Defect or Birth with Disease: congenital anomaly; adverse outcome to child
  • Needs Medical Intervention to Avoid Permanent Damage: medical treatment required

There are several different ways to file a MedWatch report with the FDA. We provide some basic information about how to file a MedWatch report on this site.

If you are interested in getting the facts of your possible drug injury claim reviewed by our law firm, click here for a free legal case evaluation.


  • US FDA advises that you should not stop taking any prescription medication before talking to your doctor.
  • Reports of serious drug side effects should be made to the US FDA MedWatch program.
  • The prescription drug names are registered trademarks of the respective drug companies.
  • DrugInjuryLaw.com is not affiliated with any of the drug companies, nor US FDA.
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